For the use only of Registered Medical Practitioners or a Hospital or a Laboratory ZODERM E CREAM. Oxiconazole Nitrate Cream

Transcription

1 For the use only of Registered Medical Practitioners or a Hospital or a Laboratory ZODERM E CREAM Oxiconazole Nitrate Cream QUALITATIVE AND QUANTITATIVE COMPOSITION ZODERM E CREAM contains: Oxiconazole 1% w/w (as Oxiconazole Nitrate micronised) Benzoic Acid I.P. 0.2% w/w (as preservative) PHARMACEUTICAL FORM Cream. CLINICAL PARTICULARS Therapeutic Indications ZODERM E CREAM is indicated for the topical treatment of superficial fungal infections of the skin caused by fungi susceptible to oxiconazole. These include dermatomycoses like tinea corporis, tinea cruris, tinea pedis and pityriasis versicolor. Posology and Method of Administration Before each use of the cream, the affected area should be carefully washed and dried. Route of Administration For cutaneous use. Adults, adolescents and children aged 8 years and above ZODERM E should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. ZODERM E should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed. 1

2 Children The decision about the indication in pediatric population should be made by a physician and the treatment should take place under medical supervision. Elderly Renal impairment Hepatic impairment Contraindications ZODERM E is contraindicated in: hypersensitivity to the active substance, imidazole derivatives, or to any of the excipients of the product. Should hypersensitivity or irritation be observed, the treatment should be discontinued and a different therapy chosen. Special Warnings and Special Precautions for Use Intravaginal administration ZODERM E is not suitable for intravaginal administration. Contact with eyes The cream should not be used around the eyes. Contact with eyes should be avoided. Interaction with Other Medicaments and Other Forms of Interaction Not known. Pregnancy and Lactation 2

3 Fertility Pregnancy and Lactation ZODERM E administration during pregnancy and lactation should be considered in terms of the ratio of the benefit to the mother and the potential risk to the fetus or child. No controlled studies have been performed in humans. ZODERM E is excreted into breast milk. Effects on Ability to Drive and Use Machines None. Undesirable Effects Clinical Trial Data Not relevant for this product. Post Marketing Data Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: Very common 1/10 Common 1/100 to <1/10 Uncommon 1/1000 to <1/100 Rare 1/10000 to <1/1000 Very rare <1/10000 Not known (cannot be estimated from the available data). Skin and subcutaneous tissue disorders Common: slight burning, itching. Uncommon: erythema (particularly in eczema). Overdose 3

4 Overdose has not been described yet. Symptoms and signs Accidental ingestion of the cream may cause nausea and vomiting. Treatment Management should be as clinically indicated or as recommended by the national poisons centre, where available. PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties Pharmacotherapeutic group: Dermatologicals, imidazole and triazole derivatives; ATC Code: D01AC11. Mechanism of Action and Pharmacodynamic Effects Oxiconazole is a synthetic imidazole derivative inhibiting the cytochrome enzyme lanosterol 14α - demethylase, which is an enzyme essential for the synthesis of ergosterol in the cell wall. Oxiconazole has a broad antifungal spectrum, which includes dermatophytes (genus Trichophyton, Microsporum, Epidermophyton), yeasts (including Malassezia furfur), filamentous and dimorphic fungi (e.g. Aspergillus, Candida). It is also active against some pathogenic bacteria (staphylococci, streptococci). Pharmacokinetic Properties Absorption of oxiconazole through the skin is negligible and therefore it is indicated for the treatment of fungal diseases of the skin. The major portion of the active ingredient applied remains in the keratinized layer of the skin; less than 1% of the applied quantity is absorbed. After the application of 150 mg of the cream, it was not detectable. Clinical Studies Not relevant for this product. Preclinical Safety Data LD50 in mice after oral (PO) administration: 3850 mg/kg. LD50 in mice (rats) after intravenous (IV) administration: 43.5 mg/kg (47.5 mg/kg). 4

5 2 studies of mutagenicity and 2 cytogenetic tests did not reveal any mutagenic effect of oxiconazole. Fertility in female rats was not impaired up to the daily dose of 3 mg/kg, in male rats up to the daily dose of 15 mg/kg. Only higher doses lead to the prolongation of oestrous cycle, hypospermia and decrease in coupling activity. Studies of teratogenicity after oral doses of 100, 150 and 200 mg/kg/day in rabbits, rats and mice revealed no adverse events in fetuses. Carcinogenicity was not studied. PHARMACEUTICAL PARTICULARS List of Excipients Benzoic acid (as preservative), cetyl alcohol, stearyl alcohol, white soft paraffin, propylene glycol, polysorbate 60 and purified water. Incompatibilities No incompatibilities have been identified. Shelf-Life The expiry date is indicated on the label and packaging. Special Precautions for Storage Store at temperature below 25 degrees C. Do not freeze. Keep out of reach of children. Nature and Specification of Container Tube in a carton Instructions for Use / Handling For external use only. There are no other special requirements for use or handling of this product. 5

6 For further information please contact: GlaxoSmithKline Pharmaceuticals Limited. Registered Office Dr. Annie Besant Road, Worli Mumbai , India. Trademarks are owned by or licensed to the GSK group of companies. Version: ZODE/PI/IN/ 2018/01 dated 31 Aug 2018 Adapted from Oxiconazole NCDS version 02 dated 26 December